7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
THERMO-FLOW SET
FDA 510(k)
FDA Class 2
·Anesthesiology
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL
FDA 510(k)
FDA Class 2
·Orthopedic
RHEUMAJET CRP
FDA 510(k)
FDA Class 2
·Immunology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·January 14, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA·Product code NIQ·December 3, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 3, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015